22 research outputs found
More than Words: Leaders' Speech and Risky Behavior During a Pandemic
How do political leader's words and actions affect people's behavior? We address this question in the context of Brazil by combining electoral data and geo-localized mobile phone data for more than 60 million devices throughout the entire country. We find that after Brazil's president publicly and emphatically dismisses the risks associated with the COVID-19 Pandemic and advises against isolation, social distancing measures of citizens in pro-government localities reduce relative to those places in which his support is weaker, while pre-event effects are insignificant. The impact is large and robust to different empirical model specifications. We also find suggestive evidence that this impact is driven by localities with relatively higher levels of media penetration
INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes
Background
The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials.
Methods
In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow.
Discussion
The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers